Kornimate/medical-research-clean huggingface dataset:
cognitive effects of immediate release topiramate vs extended release topiramate in patients with migraine

Conditions: Migraine; Headache

Summary: crossover, randomized, double blind: q12h dosing in both periods; matching placebo for evening dosing during xr treatment; target dose: 100mg

the primary objective is to compare the effect of treatment with an immediate-release topiramate (ir-tpm), namely topamax®, to an extended-release topiramate (xr-tpm), namely trokendi xr®, regimen on cognition in adults with migraine. the secondary objective is to determine the factors that explain inter-individual variability in cognitive response. pharmacokinetic and demographic factors will be explored. variability in cognitive response between individuals can be large. a population approach (nonlinear, mixed effects) will be used to determine drug exposure response relationships.

Eligibility criteria:
inclusion criteria: 1. established history of episodic migraine with or without aura, as assessed by international headache society criteria, for at least 6 months before screening and frequency of 3 or more headache attacks per month during the past 3 months 2. male or female, ages 18-65 3. women are required to be postmenopausal, surgically incapable of bearing children, or practicing a medically acceptable method of birth control (i.e., double barrier method, iud, mirena, etc) for at least 1 month before study entry through 30 days following last dose. 4. if postmenopausal and on hormone replacement therapy (hrt) then must to be on a stable regimen for at least 2 months (continuous stable regimen of cyclic or non-cyclic hrt); negative pregnancy test. 5. native english speakers (due to speech and language analysis) 6. montreal cognitive assessment (moca) score equal to or greater than 26. exclusion criteria: 1. onset of migraine occurred after age 50 years, or overuse of analgesics or migraine specific agents for the acute treatment of migraine episodes; examples of analgesic overuse included the following: more than 8 treatment episodes (episode defined as any calendar day of usage) of ergot containing medications a month; more than 8 treatment episodes of triptans a month; or more than 6 treatment episodes of potent opioids a month. 2. required, continued use of the following medications for any medical reason during the study: beta-blockers, benzodiazepines, tricyclic antidepressants, antiepileptics, calcium channel blockers, monoamine oxidase inhibitors, nonsteroidal anti-inflammatory drugs (nsaids) daily, opioids, agents for insomnia (e.g., ambien, diphenhydramine-containing otc products); corticosteroids, local anesthetics, botulinum toxin within last three months, or herbal preparations such as feverfew or st john's wort. however, subjects will be permitted to be on a stable regimen of a selective serotonin reuptake inhibitor or snri for 3 months or more for depression and/or anxiety. 3. a history of nephrolithiasis 4. have previously taken topiramate 5. received an experimental drug or used an experimental or approved device for migraine prevention (e.g., tenis unit) within 30 days of screening

Keywords: migraine headache
back pain outcomes using longitudinal data (bold)

Conditions: Low Back Pain

Summary: the overall objective of bold is to establish a large, community-based registry (at least 5000 subjects) of patients aged 65 years and older presenting with new episodes of healthcare visits for back pain. bold's primary aim is to create an infrastructure that allows for the conduct of prospective, controlled studies comparing the effectiveness of diagnostic and treatment strategies for back pain in older adults.

the bold registry identifies subjects at the time of a new episode of back pain and captures data in a longitudinal fashion for up to 12 months. the registry captures self-report outcomes data as well as comprehensive utilization data including pharmacy and imaging data through the electronic medical record system. we are applying for additional funding to continue follow-up for up to 4 years from baseline.

Eligibility criteria:
inclusion criteria: * age \>= 65 years * primary care visit for low back pain based on icd9 code * no prior visits for low back pain within six months exclusion criteria: * prior lumbar spine surgery * developmental spine deformities * inflammatory spondyloarthropathy * known spinal malignancy or infection * primarily nerve compression-related symptoms * serious medical co-morbid condition with life expectancy \< 1yr * no telephone, or planning to move within a year * unable to understand english * severe mental impairment that would interfere with answering questions

Keywords: low back pain elderly back pain lumbar pain over 65
how to predict lung recruitment at the bedside in patients affected by acute lung injury/acute respiratory distress syndrome (ali/ards)

Conditions: Acute Respiratory Distress Syndrome

Summary: the investigators aim to compare four different lung recruitment techniques (described in literature) to computed tomography scan analysis.

the investigators aim to compare four different lung recruitment techniques (described in literature) to computed tomography scan analysis: * stress index technique * peep test * recruitment technique used in the express study * recruitment technique used in the lov study

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute lung injury/ acute respiratory distress syndrome * mechanical ventilation exclusion criteria: * clinical diagnosis of chronic obstructive pulmonary disease * clinical diagnosis of pneumothorax * haemodynamic instability
the effects of increased fiber diet consumption on outcomes of subjects with visceral obesity

Conditions: Visceral Obesity

Summary: the investigators propose to undertake a controlled dietary intervention study in uae subjects with visceral obesity to examine the feasibility of a diet rich in fruits, vegetables and/or whole-grain fiber in the uae population. the research will also investigate the longer-term influence of increased fruits, vegetables and fiber consumption on health and its capacity to sustain lifestyle change.

the united arab emirates (uae) has one of the highest prevalence of obesity related diabetes mellitus in the world \[3\]. visceral (abdominal) obesity is particularly common and more closely related to morbidity in the uae. the investigators propose to undertake a controlled dietary intervention study in uae subjects with visceral obesity, the aims of which are: (i) to examine the feasibility of a diet rich in fruits, vegetables and/or whole-grain fiber in the uae population (ii) to examine the effects of increased fruits, vegetables and/or whole-grain fiber consumption on cardio metabolic risk factors (iii) to investigate the longer-term influence of increased fruits, vegetables and fiber consumption on health and its capacity to sustain lifestyle change. the proposed study will provide the scientific rationale and the methodology for improving the diet and promote healthy eating in the uae population.

Eligibility criteria:
inclusion criteria: * individuals with visceral obesity (wc=\>88 cm for women and =\>92 cm for men). exclusion criteria: * individuals with severe chronic clinical or psychiatric disease, 2) participating in other intervention trials, have a special diet or taking supplements. consent all volunteers will be required to provide informed written consent
effect of a new formulation of torasemide (prolonged release)on myocardial fibrosis in patients with heart failure.

Conditions: Congestive Heart Failure

Summary: torasemide is a loop diuretic (pyridine-sulfonylurea)with a wide experience in the treatment of oedema associated to heart failure, kidney or liver disease and either in the treatment of arterial hypertension (alone or combined with other anti-hypertensive drugs). it has been developed a new formulation of torasemide (torasemide prolonged release). the aim of this trial is to study the effects of torasemide prolonged released in comparison with furosemide, in the reduction of myocardial fibrosis in patients with chronic heart failure (class ii-iv of the new york heart association classification.


Eligibility criteria:
inclusion criteria: * aged over 18 * patients with chronic heart failure class ii-iv (nyha)due to arterial hypertension * patients clinically stable who required diuretic treatment * patients with left ventricular hypertrophy diagnosed by echocardiogram * patients without ischaemic cardiopathy or non recent disease * signed informed consent exclusion criteria: * heart failure due to aortic stenosis or hypertrophic myocardiopathy * recent coronary syndrome (less than 3 months) * recent myocardial infarction (less than 6 months) * unstable angor pectoris * severe cardiac arrhythmia * pregnancy or breastfeeding * aldosterone antagonists (last 6 months) * current loop diuretic treatment over study doses (torasemide \> 10mg/day furosemide \> 40 mg/day) * known hypersensitivity to study drugs * liver disease (sgpt or ast \> twice upper normal limt) * renal impairment (serum creatinine \> 2,5mg/dl) * insulin-dependent diabetes * patient included in another simultaneous study * lactose intolerance * lithium concomitant treatment * chronic treatment with nsaids * concomitant treatment with aminoglycoside antibiotics,etacrynic acid

Keywords: chronic heart failure torasemide prolonged release myocardial fibrosis loop diuretics peptide of procollagen type 1
lamotrigine for symptoms of geriatric bipolar depression

Conditions: Bipolar Disorder; Depression, Bipolar

Summary: this is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type i or type ii bipolar depression. non-demented older adults with bipolar i or ii depression, confirmed via the structured clinical interview for the diagnostic and statistical manual for mental disorders (dsm) - patient edition (scid-i/p) and meeting inclusion criteria for depressive symptom severity (score of 18 or greater on the hamilton depression rating scale/ham-d-24) will receive add-on lamotrigine dosed to a target of 200 mg/day.


Eligibility criteria:
inclusion criteria: * age 60 years or older * bp disorder-i or ii: depressive episode (dsm -iv-tr; scid-i/p) * ham-d score \> 18 (grid-ham-d 24-item version) * availability of an informant is encouraged but not required for study participation exclusion criteria: * chronic psychotic conditions, ie. schizophrenia, schizoaffective disorder, delusional disorder * contraindication to lamotrigine (physician interview, medical assessment) * documented history of intolerance to lamotrigine * patients who have previously failed to respond to at least 12 weeks of treatment with lamotrigine * active substance dependence (scid-i/p) or substance-related safety issues or pi concerns * mood disorder due to a general medical condition or treatment (physician interview) * rapid cycling (physician interview): as defined in dsm-iv: at least 4 episodes of mood disturbance in the previous 12 months that meet criteria for a major depressive, manic, mixed or hypomanic episode. episodes are distinguished either by partial or full remission for at least 2 months or by a switch to an episode of opposite polarity * dementia (by dsm-iv or brain degenerative diseases; physician interview); * inability to communicate in english (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in english) * clinically significant sensory impairment (i.e., cannot see well enough to read consent or visually-presented material; cannot hear well enough to cooperate with interview; physician interview) * recent history of cardiovascular, peripheral vascular events or stroke * high risk for suicide (e.g., active si or current intent or plan) * inpatient status

Keywords: geriatric psychiatry aged lamotrigine
study to determine the impact of intraoperative blood pressure management on postoperative outcomes (map-alive)

Conditions: Death; Postoperative Complications; Myocardial Infarction; Stroke; Renal Failure

Summary: the purpose of this study is to determine 1. whether intraoperative hypotension or hypertension is independently associated with postoperative mortality and morbidity 2. whether quality improvement interventions implemented at the university of michigan and at washington university: 1. decrease the extent and duration of intraoperative hypotension and hypertension. 2. are associated with decreased postoperative mortality and morbidity.

recent epidemiological data from an european study suggests that the 30-day postoperative mortality rate reaches a rate of about 1 in 50. a similar rate has been observed at barnes-jewish hospital (bjh) according to the investigators published and unpublished data from the b-unaware (nct00281489) and bag-recall (nct00682825) clinical trials. many factors are associated strongly and independently with postoperative morbidity and mortality; including patient age, functional status, comorbid medical conditions, and duration and invasiveness of the surgery. it is imperative to identify modifiable factors for possible intervention. with the advent of electronic intraoperative medical record, intraoperative hemodynamic factors can be assessed as a potential contributor to postoperative morbidity and mortality. recent studies have shown that intraoperative hypotension occurs commonly and is associated with both early and late postoperative mortality. the investigators goal is to conduct a study that might help to clarify whether intraoperative blood pressure management might be interdependently associated with postoperative morbidity and mortality. there are two phases in this trial: pre-quality improvement phase and post quality improvement phase. pre-quality improvement phase data will be used as a baseline control group. data from this phase will also be used to establish whether there appears to be an independent association between intraoperative blood pressure management and postoperative morbidity and mortality. the anesthesiology departments at washington university in st. louis and at the university of michigan are implementing quality improvement initiatives in relation to intraoperative blood pressure management. following implementation of the quality improvement initiatives, the investigators plan to determine whether: a) there is an improvement in intraoperative blood pressure management; b) whether there is a decrease in postoperative morbidity and mortality.

Eligibility criteria:
inclusion criteria: * all patients undergoing surgery at barnes-jewish hospital or the university of michigan between 8/1/2009 and 10/31/2012 exclusion criteria: * patients undergoing organ harvest or terminal surgical procedure (american society of anesthesiologists physical status 6) * patients without a social security number

Keywords: blood pressure mean arterial pressure map intraoperative postoperative anesthesia
percutaneous excision trial

Conditions: Imaged Breast Abnormalities

Summary: to confirm that a definitive diagnosis can be made from the tissue sample collected using the intact bles when defined radiology and pathology criteria are met.


Eligibility criteria:
inclusion criteria: * patient must be a female at least 18 years of age at the time of intact bles biopsy * patient must have had an imaged abnormality found via mammography or sonography that warrants a biopsy for further diagnosis exclusion criteria: * patients who have pre-pectoral breast implants * patients who have implantable devices such as pacemakers and defibrillators * patients who are pregnant or lactating * patients in whom the device is contraindicated * patients who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed or who exhibit fever or other clinical evidence of infection
alternative carer respite: a study on its effectiveness and potential mechanism

Conditions: Caregiver Burden

Summary: the primary objective of this study is to examine the effectiveness of alternative carer respite in meeting the unique needs of older adults without children or with limited contact with their children in hong kong. caregivers are assessed before and after the intervention, and three months after the end of intervention on their physical health, mental well-being, social engagement, and overall satisfaction.

all participants will provide informed consent at the time of enrolment. both caregivers and their care recipients will complete an assessment. caregivers are screened for their physical health, mental well-being, social engagement, and overall satisfaction. care recipients are screened using interrai for their physical functions. caregivers will receive a maximal of 48 hours of respite service within 6 month. alternative caregivers will provide in-home elderly-sitting service so that the caregivers can have some private time for themselves. at the end of the service period, caregivers and care recipients will complete the assessment again to measure the changes of their physical and mental health. all participants will be contacted again for follow-up assessment 3 months after the completion of service.

Eligibility criteria:
inclusion criteria: * either the cr or cg is aged ≥60 * reported having (a) no children; or (b) no children in hong kong; or (c) having children in hong kong but with limited contact (i.e., fewer than once per month in any forms) * voluntary participation. exclusion criteria: * unable to communicate in neither cantonese, english nor mandarin

Keywords: respite caregiver burden
study of capecitabine in metastatic non-clear cell renal cell carcinoma (rcc) patients

Conditions: Metastatic Renal Cell Carcinoma

Summary: capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. the role of capecitabine in treatment of metastatic renal cell carcinoma is discussed. in this trial, we are evaluating efficacy of capecitabine in metastatic renal cell carcinoma patients.


Eligibility criteria:
inclusion criteria: * histologically confirmed non-clear cell renal cell carcinoma * confirmed metastatic sites * no chemotherapy in history exclusion criteria: * metastases in cns * previous targeted therapy * other tumor
use of dobutamine in patients with sepsis and maintained hypoperfusion after initial volemic resuscitation.

Conditions: Sepsis; Hypoperfusion; Hyperlactatemia

Summary: this phase 2 study aim to investigate the effect of dobutamine in patients with sepsis/ septic shock after fluid resuscitation and with hypoperfusion (lactate and central venous oxygen saturation or prolonged capillary refill time) on renal function as compared with usual care.

in this phase 2 study patients with sepsis/ septic shock and signs of persistent hypoperfusion after fluid resuscitation will be randomized to receive either dobutamine or no intervention in addition to usual care. dobutamine will be used for 48 hours. hypoperfusion will be assessed by altered lactate levels and a low svo2 or prolonged capillary refill time. both arms will receive usual care according to the surviving sepsis campaign guidelines. dobutamine dosis will be adjusted to achieve improvement in the perfusion parameters according to a pre specified protocol. pre specified criteria will be used to stop the drug for safety. the primary outcome will be creatinine at day 3. other secondary and safety outcomes will also be assessed.

Eligibility criteria:
inclusion criteria: * over 18 years old * patient with sepsis (suspected or confirmed) for less than 48 hours with: adequate volume resuscitation with 30 ml/kg of crystalloid solution or assessment by the attending physician that fluid resuscitation is no longer indicated signs of hypoperfusion for less than 12 hours assessed by arterial lactate over two times the reference value and central venous saturation (svco2) less than 66% or capillary refill time greater than 3 seconds. exclusion criteria: * pregnancy * risk of imminent death within the next 12 hours in the opinion of the attending physician * patients under end of live care * previous congestive heart failure in functional class iv and/or dependence for all basic activities of daily living * hemoglobin levels below 7.0 g/dl * current use of dobutamine * patients in renal replacement therapy

Keywords: sepsis hypoperfusion dobutamine
a real world study to evaluate effectiveness of avastin (bevacizumab) for first line treatment of patients with metastatic colorectal cancer and known kras status

Conditions: Colorectal Cancer

Summary: this non-interventional study will meta-analyze overall survival outcomes among the participants with metastatic colorectal cancer (mcrc) with available v-ki-ras2 kirsten rat sarcoma viral oncogene homolog (kras) status, who received firstline treatment with bevacizumab containing treatment regimen in routine clinical practice. the study leveraging secondary data from existing cohorts in the united stats of america (usa), germany, australia, and denmark.


Eligibility criteria:
inclusion criteria: * participants with metstatic colorectal cancer (mcrc) diagnosed at any point prior to march 2014 (united states \[us\] - vector oncology protocol sponsored by us roche pharma medical affairs), diagnosed between september 2006 and march 2015 (germany - tumourregister kolorektales karzinom \[tkk\] registry study supported by german roche pharma affiliate), diagnosed between september 2009 and december 2014 (australia - treatment of recurrent and advanced colorectal cancer \[tracc\] registry supported by roche pharma australia), diagnosed between 2009 and 2013 (denmark - roche diagnostic sponsored study and aarhus university hospital, department of clinical epidemiology) * participants have been treated in first line with bevacizumab or anti-egfr treatment regimen or chemotherapy alone * participants have to have available data on overall survival (os), kras testing status, and left/right tumor location status exclusion criteria: n/a
comparing exertional heat illness risk factors between patients and controls

Conditions: Exertional Heat Illness

Summary: the arduous nature of military training and operations require personnel to encounter high heat load, e.g., during intense physical exertion, particularly in the heat. these conditions reduce operational effectiveness and expose personnel to a risk of incapacitation and death from exertional heat illness (ehi). the primary aim of this study is to compare putative 'chronic' ehi risk factors between a cohort who have suffered a history of ehi and a control cohort with no ehi history. the secondary aim is to examine the influence of these ehi risk factors on thermoregulation during a standard heat tolerance assessment.

military training and operations present a risk of incapacitation and death from exertional heat illness (ehi). however, widely accepted ehi risk factors are absent in almost half of all united kingdom (uk) military ehi cases, indicating that a significant number of ehi cases in military personnel involve alternative risk factors. risk factors for ehi can been classified along a spectrum ranging from acute (e.g. recent poor sleep) to chronic (e.g. low fitness), with the role of chronic risk factors supported by the observation that individuals who have suffered an ehi are at a substantially increased risk of subsequent ehi. the primary aim of this study is to compare putative 'chronic' ehi risk factors (e.g. composition of gastrointestinal (gi) microbiome, infection and inflammation, trait-like psychological factors) between a cohort who have suffered a history of ehi and a control cohort with no ehi history. the secondary aim is to examine the influence of these ehi risk factors on thermoregulation during a standard heat tolerance assessment.

Eligibility criteria:
inclusion criteria: individuals with a history of ehi: * previous ehi episode * normal resting ecg * male or female * 18 - 40 years control participants: * no previous history of ehi * normal resting ecg * male or female * 18 - 40 years